Federal Register / Vol. 71, No.

137 / Tuesday, July 18, 2006 / Notices 40721

involving individual Federal Reserve send comments to Seleda Perryman, conditions. Participants in the treatment
System employees. CDC Assistant Reports Clearance condition, will be exposed to campaign
2. Any items carried forward from a Officer, 1600 Clifton Road, MS–D74, materials including radio
previously announced meeting. Atlanta, GA 30333 or send an e-mail to advertisements, a billboard, and an
FOR FURTHER INFORMATION CONTACT: omb@cdc.gov. informational booklet that will be
Michelle Smith, Director, or Dave Comments are invited on: (a) Whether distributed over the Internet. Thus the
Skidmore, Assistant to the Board, Office the proposed collection of information study participants’ exposure will occur
of Board Members at 202–452–2955. is necessary for the proper performance under controlled conditions, without
SUPPLEMENTARY INFORMATION: You may of the functions of the agency, including the distractions and variability of
call 202–452–3206 beginning at whether the information shall have potential exposure in the real world. As
approximately 5 p.m. two business days practical utility; (b) the accuracy of the part of the advertisement stimuli
before the meeting for a recorded agency’s estimate of the burden of the package, the billboard advertisement
announcement of bank and bank proposed collection of information; (c) will appear as part of the online log-in
holding company applications ways to enhance the quality, utility, and for each stimuli session in order to
scheduled for the meeting; or you may clarity of the information to be simulate the appearance of a sign.
contact the Board’s Web site at http:// collected; and (d) ways to minimize the Therefore, we do not estimate any
www.federalreserve.gov for an electronic burden of the collection of information additional burden for exposure to the
announcement that not only lists on respondents, including through the billboard advertisement.
applications, but also indicates use of automated collection techniques
or other forms of information Key outcomes related to the HTSMC
procedural and other information about will be measured in two follow-up
the meeting. technology. Written comments should
be received within 60 days of this surveys. The first follow-up survey will
Board of Governors of the Federal Reserve notice. occur 2 weeks after the baseline survey.
System, July 14, 2006. The second follow-up survey will occur
Robert deV. Frierson, Proposed Project 6 weeks after the baseline survey.
Deputy Secretary of the Board. Evaluation of the HIV Testing Social Comparisons of changes in these
[FR Doc. 06–6351 Filed 7–14–06; 2:44 pm] Marketing Campaign (HTSMC)—New— outcomes would then be made between
BILLING CODE 6210–01–S National Center for HIV/AIDS, Viral participants in the treatment and control
Hepatitis, STD, and TB Prevention conditions. Findings from this study
(NCHHSTP), Coordinating Center for will be used by CDC and its partners to
DEPARTMENT OF HEALTH AND Infectious Diseases (CCID), Centers for inform current and future program
HUMAN SERVICES Disease Control and Prevention (CDC). activities.
Background and Brief Description We expect a total of 1,630 participants
Centers for Disease Control and to complete the baseline survey. The
Prevention This project involves the evaluation of
the HIV Testing Social Marketing 1,630 participants who complete the
[60Day-06–06BL] Campaign (HTSMC), a CDC-sponsored baseline survey will be randomly
social marketing campaign aimed at assigned to the treatment or control
Proposed Data Collections Submitted condition. 815 participants (the
increasing HIV testing rates among
for Public Comment and treatment condition) will be exposed to
young, single, African American
Recommendations the radio ad and booklet. Of the 1,630
women. The CDC has designed an
In compliance with the requirement efficacy study to evaluate the HTSMC participants who completed the baseline
of section 3506(c)(2)(A) of the and its messages under controlled survey, we expect 1,140 to complete the
Paperwork Reduction Act of 1995 for conditions. The study entails selecting a first follow-up survey. Of the 1,140 who
opportunity for public comment on sample of single African American complete the first follow-up survey, we
proposed data collection projects, the females, ages 18 to 34, with less than 4 expect 800 to complete the second
Centers for Disease Control and years of college education and collecting follow-up survey, which will have fewer
Prevention (CDC) will publish periodic baseline data on their knowledge, questions than the first follow-up survey
summaries of proposed projects. To attitudes, beliefs, intentions, and because it will only pertain to questions
request more information on the behaviors related to HIV testing. The about behavior change and selected
proposed projects or to obtain a copy of study represents an ‘‘efficacy’’ behavioral intentions.
the data collection plans and methodology in that participants will be There are no costs to the respondents
instruments, call 404–639–5960 and divided into treatment and control other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS

Average
Responses Total
Number of burden per
Respondents per burden
respondents response (in
respondent hours
hours)

Baseline survey ............................................................................................................. 1,630 1 15/60 408

Radio ad stimuli viewing ............................................................................................... 815 1 18/60 245
Booklet reading ............................................................................................................. 815 1 15/60 204
Follow-up survey 1 ........................................................................................................ 1,140 1 15/60 285
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Follow-up survey 2 ........................................................................................................ 800 1 5/60 67

Total ....................................................................................................................... .................... .................... ...................... 1,209

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 40722 Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices
Dated: July 10, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–11340 Filed 7–17–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0333]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance:
Emergency Use Authorization of
Medical Products
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 17,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Draft Guidance: Emergency Use
Authorization of Medical Products
The Federal Food, Drug, and Cosmetic
Act (the act) permits the Commissioner
of FDA (the Commissioner) to authorize
the use of unapproved medical products
wwhite on PROD1PC61 with NOTICES
or unapproved uses of approved
medical products during an emergency
declared under section 564 of the act (21
U.S.C. 360bbb–3). The data to support
issuance of an emergency use
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authorization (EUA) must demonstrate
that, based on the totality of the
scientific evidence available to the
Commissioner, including data from
adequate and well-controlled clinical
trials (if available), it is reasonable to
believe that the product may be effective
in diagnosing, treating, or preventing a
serious or life-threatening disease or
condition (21 U.S.C. 360bbb–3(c)).
Although the exact type and amount of
data needed to support an EUA may
vary depending on the nature of the
declared emergency and the nature of
the candidate product, FDA
recommends that a request for
consideration for an EUA include
scientific evidence evaluating the
product’s safety and effectiveness,
including the adverse event profile for
diagnosis, treatment, or prevention of
the serious or life-threatening disease or
condition, as well as data and other
information on safety, effectiveness,
risks and benefits, and (to the extent
available) alternatives.
Under section 564 of the act, the
Commissioner may establish conditions
on the approval of an EUA. Section
564(e) requires the Commissioner (to the
extent practicable given the
circumstances of the emergency) to
establish certain conditions on an
authorization that the Commissioner
finds necessary or appropriate to protect
the public health and permits the
Commissioner to establish other
conditions that he finds necessary or
appropriate to protect the public health.
Conditions authorized by section 564(e)
of the act include, for example:
Requirements for information
dissemination to health care providers
or authorized dispensers and product
recipients; adverse event monitoring
and reporting; data collection and
analysis; recordkeeping and records
access; restrictions on product
advertising, distribution, and
administration; and limitations on good
manufacturing practices requirements.
Some conditions, the statute specifies,
are mandatory to the extent practicable
for authorizations of unapproved
products and discretionary for
authorizations of unapproved uses of
approved products. Moreover, some
conditions may apply to manufacturers
of an EUA product, while other
conditions may apply to any person
who carries out any activity for which
the authorization is issued. Section 564
of the act also gives the Commissioner
authority to establish other conditions
on an authorization that the
Commissioner finds to be necessary or
appropriate to protect the public health.
For purposes of estimating the burden
of reporting, FDA has established six
PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM
categories of respondents which
include: (1) Those who file a Request for
Consideration for an EUA after a
determination of actual or potential
emergency and, in lieu of submitting the
data, provide reference to a pending or
approved application; (2) those who file
a Request for Consideration for an EUA
and the data after a determination of
actual or potential emergency, without
reference to a pending or approved
application; (3) those who submit data
to FDA on a candidate EUA product,
which is subject to a pending or
approved application, prior to a
determination of actual or potential
emergency; (4) those who submit data to
FDA prior to a determination of actual
or potential emergency about a
candidate EUA product for which there
is no pending or approved application;
(5) manufacturers of an unapproved
EUA product who must report to FDA
regarding such activity; and (6) State
and local public health officials who
carry out an activity related to an
unapproved EUA product (e.g.,
administering the product to civilians)
and who must report to FDA regarding
such activity.
For purposes of estimating the burden
of recordkeeping, FDA has calculated
the anticipated burden on
manufacturers of unapproved products
authorized for emergency use. The
agency anticipates that the Federal
Government will perform some of the
additional recordkeeping necessary for
unapproved products (e.g., related to the
administration of unapproved EUA
products to military personnel). FDA
also anticipates that some State and
local public health officials may be
required to perform additional
recordkeeping (e.g., related to the
administration of unapproved EUA
products to civilians) and calculated a
recordkeeping burden for those
activities.
No burden was attributed to reporting
or recordkeeping for unapproved uses of
approved products, because those
products already are subject to approved
collections of information (adverse
experience reporting for biological
products is approved under OMB
control number 0910–0308 through May
31, 2005; adverse drug experience
reporting is approved under OMB
control number 0910–0230 through
September 30, 2005; and investigational
new drug applications (IND) regulations
are approved under OMB control
number 0910–0014 through January 31,
2006), and any additional burden
imposed by this proposed collection
would be minimal. Thus, FDA estimates
the burden of this collection of
information as follows:
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